Tolterodine Tartrate
- Product NDC
- 0378-3402
- 11-digit product format
- 003783402
- Labeler code
- 0378
- Product ID
- 0378-3402_03852abe-992e-4d0b-a105-19ca8faba01e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tolterodine Tartrate
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA201486
- Marketing category
- ANDA
- Marketing start
- 2013-10-31
- Marketing end
- 0000-00-00
- Substance
- TOLTERODINE TARTRATE
- Active strength
- 2 mg/1
- Pharmacologic classes
- Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
Dataset, Scope, Product NDC table| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|
| excluded product | product | 0378-3402 | | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 0378-3402 | 0378-3402-05 | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 0378-3402 | 0378-3402-93 | D | Discontinued by firm | | 2026-07-31 |
Orange Book products#
Application-product, Trade name, Ingredient table| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|
| A201486-001 | TOLTERODINE TARTRATE | TOLTERODINE TARTRATE | 2MG | CAPSULE, EXTENDED RELEASE / ORAL | | | 2013-10-31 |
| A201486-002 | TOLTERODINE TARTRATE | TOLTERODINE TARTRATE | 4MG | CAPSULE, EXTENDED RELEASE / ORAL | | | 2013-10-31 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| TOLTERODINE TARTRATE | ACTIVE INGREDIENT | 5T619TQR3R | TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.] | 3 | |
| TOLTERODINE | ACTIVE MOIETY | WHE7A56U7K | TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.] | 3 | |
| ETHYLCELLULOSES | INACTIVE INGREDIENT | 7Z8S9VYZ4B | TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.] | 3 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.] | 3 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.] | 3 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.] | 3 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.] | 3 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.] | 3 | |
| POTASSIUM HYDROXIDE | INACTIVE INGREDIENT | WZH3C48M4T | TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.] | 3 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.] | 3 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.] | 3 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.] | 3 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.] | 3 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.] | 3 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.] | 3 | |
| TOLTERODINE TARTRATE | ACTIVE INGREDIENT | 5T619TQR3R | TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.] | 1 | |
| TOLTERODINE | ACTIVE MOIETY | WHE7A56U7K | TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.] | 1 | |
| ETHYLCELLULOSES | INACTIVE INGREDIENT | 7Z8S9VYZ4B | TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.] | 1 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.] | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.] | 1 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.] | 1 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.] | 1 | |
| POTASSIUM HYDROXIDE | INACTIVE INGREDIENT | WZH3C48M4T | TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.] | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.] | 1 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.] | 1 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.] | 1 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.] | 1 | |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0378-3402-05 | 00378340205 | 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-3402-05) | 2013-10-31 | 0000-00-00 | No | No | Current |
| 0378-3402-93 | 00378340293 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-3402-93) | 2013-10-31 | 0000-00-00 | No | No | Current |